Pediatric Acute Gastrointestinal Bleeding Registry

A. Specific Aims/Objectives:

The goal of this study is to identify significant clinical and laboratory risk factors in
pediatric patients with significant upper gastrointestinal bleeding. This is defined as
bleeding that necessitates an upper endoscopic evaluation to either diagnose or treat upper
GI bleeding during their hospital admission. If a predictive/risk stratification relationship
exists, these data could permit a more effective triaging and intervention scheme in
pediatric patients presenting with complaints of gastrointestinal bleeding. In addition we
want to get a better understanding of the re-bleeding rate after endoscopic therapy for upper
GI bleeding and if there are any identifiable risk factors for re-bleeding. Lastly we want to
understand best practice management for upper GI bleeding.

B. Background and Significance:

Gastrointestinal (GI) hemorrhage is a potentially life-threatening presentation that the
pediatric gastroenterologist must recognize, and manage appropriately. Classification is
generally divided between upper or lower GI bleeding, based on the origin of bleeding
relative to hemorrhages the Ligament of Treitz. The incidence of GI bleeding in children is
not well established in the pediatric population. For upper GI bleeds most large, prospective
studies have assessed incidence in pediatric critical care settings. In one prospective study
of 984 patients, upper GI bleeds occurred in 6.4% of admissions receiving on prophylactic
therapy. Other studies have shown upper GI bleeding in as many as 25% of pediatric intensive
care admissions without prophylaxis. There is no data on the incidence of pediatric GI bleeds
that requires endoscopic therapy.

Pediatric studies are lacking with respect to risk stratification and decisional algorithms
in managing pediatric acute upper gastrointestinal bleeding. Adult literature supports
accurate stratification of risk based on clinical history, physical examination, and
laboratory measures. Additionally, endoscopic interventions not only allow for therapeutic
interventions but also prognosticate based on visual findings. Similar pediatric literature
is not available thus giving rise to large amounts of variability both center to center as
well as within centers regarding management decision making.

C. Design and Methods:

- Prospective, observational analysis of inpatient and ambulatory records of pediatric
patients at Boston Children's Hospital beginning upon IRB approval.

- We will identify pediatric patients room, ambulatory clinic or as current inpatients who require endoscopic evaluation for
acute upper gastrointestinal bleed and potential treatment.

- Data collected will include clinical signs and symptoms and physical exam features,
laboratory studies and endoscopic findings

- Identified patients will then be followed prospectively for outcomes data collection.

- Data collection will include:

- Clinical history of bleeding onset, acuity, amount, frequency and prior history of
gastrointestinal bleed.

- Medication history

- Physical examination data including vital signs (heart rate, blood pressure, and
oxygen saturation)

- Laboratory data including

- Complete blood count

- Inflammatory markers (ESR and CRP)

- Liver panel

- Complete Metabolic Panel

- Urinanalysis

- Endoscopic findings as well as data from interventions (cautery, clips, injections)

- Medical management decisions (acid suppression therapy, oral intake, frequency of
laboratory measurement)

- Outcome data including re-bleeding rates (with respect to endoscopic intervention),
laboratory measures, and length of stay.

Inclusion Criteria:

- All pediatric patients will selected based on signs and symptoms of upper
gastrointestinal bleeding and their need to have an upper endoscopy performed.

Exclusion Criteria: